Description

Bivalirudin Impurity 3 is a structurally defined degradation product and synthetic intermediate critical for the quality control and regulatory validation of the anticoagulant drug bivalirudin. It serves as an essential reference standard for method development, stability studies, and impurity profiling in pharmaceutical manufacturing and regulatory submissions. This compound is indispensable for contract research organizations (CROs), active pharmaceutical ingredient (API) manufacturers, and quality control laboratories engaged in thrombin inhibitor development and GMP-compliant production. Bivalirudin Impurity 3 CAS NO 1310025-28-5 supports rigorous analytical assurance across global pharmacopoeial compliance frameworks.

Application

• Reference standard for HPLC and UPLC method validation in bivalirudin API release testing
• Stability-indicating assay component for forced degradation studies (hydrolysis, oxidation, photolysis)
• Calibration material for quantitative impurity determination per ICH Q3B(R2) guidelines
• Qualification standard in regulatory filings (FDA ANDA, EMA MAA, PMDA NDA) for bivalirudin products
• Internal QC benchmark for in-process controls during bivalirudin synthesis and purification
• Proficiency testing material for accredited pharmaceutical testing laboratories (ISO/IEC 17025)
• Supporting documentation for USP monograph compliance and EP 10.0 chapter 5.10 impurity verification
• Research tool for structure–activity relationship (SAR) studies of thrombin-binding peptide analogues

Basic Information

Product Name	Bivalirudin Impurity 3
CAS No.	1310025-28-5
Molecular Formula	C65H102N18O19S2
Molecular Weight	1427.74 g/mol
Synonyms	[D-Phe]-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu; Bivalirudin Related Compound C; Bivalirudin Degradant 3; Bivalirudin Impurity C; D-Phe¹-Bivalirudin; Des-D-Phe¹-Bivalirudin; [D-Phe¹]-Bivalirudin; Bivalirudin (des-D-Phe¹); Bivalirudin (N-terminal dephosphorylated variant)
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches are tested per ICH Q5R1 and Q7 guidelines, with full traceability to primary reference standards. Testing includes identity confirmation (HPLC retention time match + IR spectroscopy), assay (HPLC area normalization), residual solvents (GC), heavy metals (USP <231>), and microbiological limits (USP <61>). Products meet or exceed requirements for pharmaceutical-grade reference standards under USP, EP, and JP compendial methods.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (argon or nitrogen) to prevent degradation. Due to its hygroscopic nature, maintain low-humidity conditions (<30% RH) and minimize exposure to ambient air during handling. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (IR)	Conforms to reference standard spectrum
Identification (HPLC)	Retention time matches reference standard (±0.2 min)
Assay (HPLC)	98.0–102.0%
Related Substances (HPLC)	Single impurity ≤ 0.5%; Total impurities ≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits (Acetonitrile ≤ 410 ppm, Water ≤ 5.0%)
Water (KF)	≤ 5.0%
Heavy Metals	≤ 10 ppm
Microbial Limits	Total aerobic count ≤ 100 CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, S. typhi

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.